FDA Orphan Drug Designation is a critical regulatory milestone that can significantly impact a biotech company's valuation and market position. For Harmony Biosciences, this designation for Pitolisant not only validates the drug's potential but also offers various benefits including tax credits, eligibility for grant funding, and potentially seven years of market exclusivity upon approval. These factors are likely to positively influence HRMY's stock price in the short term as they reduce development risk and potentially accelerate the timeline to commercialization.